Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia

Recruiting

• Conditions: Infectious Complications (Epidural Abscess or Meningitis); Obstetrical Neuraxial Anaesthesia
• Interventions: Other: Non applicable

• Registration Number: NCT06449066
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to evaluate if neuraxial anesthesia (epidural or intradural anesthesia) used during childbirth is associated with more frequent infectious complications in patients with primary immunodeficiencies (PID).

Detailed Description

Neuraxial anaesthesia (epidural or intradural) is often used to alleviate pain during labour and childbirth. Although extremely efficient and safe, rare but serious infectious complications such as epidural abscess or meningitis can occur afterwards.

Patients with PID tend to have a greater risk of infectious complications than the general population. With the progress of medical care in those pathologies, female patients are now giving birth more often. The use of neuraxial anaesthesia and the associated infectious complications have never been studied in this population.

The investigators intend to review the medical records of PID patients who gave birth in an APHP hospital in the last 10 years to evaluate the use of neuraxial anesthesia and the frequency of infectious complications associated with neuraxial anesthesia.

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-07
• Status Verified: 2024-08
• Study Start: 2024-08-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Female patient included in the CEREDIH national register
• Aged > 18 years

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Exclusion Criteria

• Refuse to participate
• Deceased
• Minor
• under judicial protection
• obstetric file not available

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Non applicable	CEREDIH (centre de reference des deficits immunitaires héréditaires) cohort Female patients, alive and \> 18 years old, registered at the CEREDIH who gave birth in an APHP maternity

Primary Outcome Measures

Name	Time	Method
Number of participants who develop a local or systemic infection, such as an epidural abscess or meningitis, within 28 days after receiving neuraxial anesthesia during delivery	28 days post-partum	Occurrence of a local or systemic infection post-neuraxial anesthesia within 28 days after delivery / Infectious complication after obstetrical neuraxial anesthesia / Epidural abscess or meningitis after neuraxial anesthesia

Secondary Outcome Measures

Name	Time	Method
Number of cases where maternity anesthetists identify contraindications to performing neuraxial anesthesia in patients with primary immunodeficiency	During labour	Possible occurrence of contraindications identified by the maternity anesthetist to the performance of neuraxial anesthesia linked to primary immunodeficiency
Frequency of Alternative Pain Relief Methods Utilized Due to Contraindications Linked to Primary Immunodeficiency	During labour	Use of an alternate method for pain-relief during childbirth / Use of another method of pain relief due to a contraindication linked to primary immunodeficiency
Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia	up to 24 hours after birth	Use of a antibioprophylaxis when performing neuraxial anesthesia

Trial Locations

Locations (1)

Infectiology mobile team - Department of Infectious and Tropical Diseases; 🇫🇷 Paris, Ile De France, France